NCT05084781

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

Detailed description

Prospective, Double blind, Randomized controlled trial. Male and female subjects, over the age of 18 years. Full thickness rotator cuff tear, requiring surgical repair. Patient undergoes pre- and intra-operative assessment, and once eligibility is confirmed intra-operatively, patient is randomly assigned to receive either a) coblation debridment, or b) mechanical debridement. Standard post-operative rehab program for all patients. Follow-up occurs at 3, 6, 12, and 24 months post operatively and includes physical exam and patient based outcomes (questionnaires).

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
PROCEDURE	Coblation Debridement (FLOW90)	bipolar radiofrequency energy

Timeline

• Start date: 2020-07-08
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study